Georgia Judge: BioAnue Labs Must Provide Proof of FDA Compliance Before Selling Supplements

On Thursday, Chief Judge Marc Treadwell of the Middle District of Georgia ordered BioAnue Laboratories Inc. and two individuals to submit documentation detailing how they will comply with Food and Drug Administration (FDA) regulations that the court found they were circumventing.

The United States’ 2013 complaint against BioAnue, CEO Gloria Raber, and her husband, Kelly Raber, sought a permanent injunction under the Food, Drug, and Cosmetic Act (FDCA) to restrict the defendants from marketing and selling products through their website that the U.S. characterized as drugs. Products with a drug classification are subject to the FDA’s standards that require approval to be circulated, the U.S. noted; however, these are standards that BioAnue did not meet.

The court granted the injunction, which permanently barred the defendants from continuing to sell any drug or dietary supplement product until they complied with certain requirements, including those under the FDCA related to labeling and quality control. The defendants moved to vacate the injunction in February, contending that they have been in “full compliance” with the terms of the injunction for seven years. According to the court, the defendants want to begin selling dietary supplements through a new website as a wholesaler, meaning the defendants themselves would not be the manufacturers.

The government argued that the same regulations would still apply and the defendants are aware; the FDA told them in a letter that they still are “prohibited from buying dietary supplements and reselling to the public” unless they conform to the injunction’s requirements. However, the defendants, in a letter to the court, said they “do not understand … why (they are) banned from selling dietary supplements that are already on the market—products manufactured and sold by other FDA-registered companies.”

The U.S. noted, in a response, that selling third-party dietary supplements “is still ‘introducing’ supplements ‘into interstate commerce,’ ” which the defendants are unable to do under the injunction unless they prove their compliance.

“The defendants did not reply to the Government’s response,” the court said. “Specifically, they make no effort to show how their new venture will conform to the relevant regulations.”

The court allowed the defendants 30 days to provide documentation proposing how their new venture will comply with FDA standards.

Smith & Harrington, Burke Lasseter LLC, and Cliff Carlson Law P.C. represent the defendants.